Severe Forms of Mucous Membrane PemphigoidPhase 3RITUX-MMPNCT03295383

Randomized Clinical Trial Comparing the Safety and Efficacy of Rituximab Versus Oral Cyclophosphamide in Severe Forms of Mucous Membrane Pemphigoid

A Phase 3 study testing Rituximab 1g IV and Cyclophosphamide 50Mg Oral Tablet in people with Severe Forms of Mucous Membrane Pemphigoid, run by University Hospital, Rouen at 27 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Severe Forms of Mucous Membrane Pemphigoid
What is being tested?: Rituximab 1g IV and Cyclophosphamide 50Mg Oral Tablet
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 92 participants
Where: 27 sitesFrance
Study dates: 11 Jul 2019to Mar 2027
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female patients aged ≥18 years old and ≤ 80 years old with a newly diagnosed or previously diagnosed severe MMP diagnosed according to the International MMP Consensus (Chan 2002) on the following criteria:
Clinical features: Blisters or erosions predominantly affecting any or all mucous membranes (oral, nasal, pharyngeal, laryngeal, anal, genital, or esophageal,) with or without clinically observable scarring. Ocular involvement includes conjunctival inflammation, shortening of fornices, symblepharon, ankyloblepharon, entropion, trichiasis and corneal neovascularisation.
Patients with skin involvement must not have more than 2 out of the 4 clinical criteria for bullous pemphigoid (BP) proposed by the French group (Vaillant L et al,1998; Joly P et al. 2004) Direct Immunofluorescence (DIF): Linear deposits of IgG, IgA and/or C3 on the BMZ by DIF of patient's skin or mucous membrane Histology: Sub epithelial blister with or without significant leukocyte infiltrate by standard histology of skin or mucosal lesions, when the skin or mucosal biopsy is possible and appropriate.
MMP is defined as "severe" in patients with:
Sight-threatening ocular disease, and/or Potentially life-threatening laryngeal, tracheal or oesophageal stenosis, and/or Involvement of a mucosal site where there is a risk of scarring stenosis (larynx, trachea, esophagus, anus, foreskin, vagina…) and/or More than one mucosal site involved and/or Mucosal involvement (including exclusive but severe oral involvement defined as an oral MMP DAI score > 10), and/or Skin involvement, which have not achieved control of disease activity despite a one month treatment with dapsone at the maximum dose tolerated or for patients with sight-threatening ocular disease, and/or potentially life-threatening laryngeal, tracheal or oesophageal stenosis, without previous treatment by dapsone
Patient having read and understood the information letter and signed the Informed Consent Form

Show all 17Show fewer

Patient with updated vaccinations. It is recommended that a patient's vaccination record and the need for immunization prior to study entry be carefully investigated.
For women who are not postmenopausal (≥12 months of non-therapy-induced amenorrhoea) or surgically sterile (absence of ovaries and/or uterus) and who do not plan on having children anymore: agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of <1% per year, during the treatment period and for at least 12 months after the last dose of study treatment.
Abstinence is acceptable only if it is in line with the preferred and usual lifestyle of the patient.
Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
Barrier methods must always be supplemented with the use of a spermicide.
For men: Surgical sterility or agreement to remain abstinent or use a condom during the treatment period and for at least 12 months after the last dose of study treatment and agreement to refrain from donating sperm during this same period.
Abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the patient.
Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
Patient agreement to avoid excessive exposure to sunlight during study participation
Patient able to comply with the study protocol, in the investigator's judgment
Patient affiliated with, or beneficiary of a social security category

Who cannot join

Patient < 18 years old or > 80 years old
Non-consenting patient or patient who cannot be followed regularly
Patients with only MMP sequelae (stenosis, fibrosis, without inflammation or disease activity)
Patients with Brunsting Perry pemphigoid and exclusive skin lesions without mucosal involvement
Karnofsky index < 50% (see Appendix 3)
Unstable angina or advanced ischemic cardiopathy (extensive myocardial infarction within the last 3 months or post-infarction heart failure)

Show all 40Show fewer

Severe heart failure (NYHA Class III or IV) or severe uncontrolled cardiac disease
Uncontrolled cardiac rhythm disorders
Severe bronchial obstruction
Past history of malignant disease in the previous 10 years, or current progressive malignant disease, except basal cell carcinoma, and squamous cell carcinoma of the skin that have been treated or excised and cured, in situ cervix carcinoma, or any situation in which the oncologist in charge of the patient considers that risk of evolution of severe localisation(s) of MMP is higher than oncologic risk of cyclophosphamide and rituximab.
Anemia (haemoglobin < 10 g/ dL ), neutropenia (<1000/mm3), lymphopenia (<900/mm3), thrombopenia (<100 000/mm3)
Positive test results for hepatitis B surface antigen (HBsAg), hepatitis B core, antibody (HBcAb), or hepatitis C virus (HCV) serology at screening
Liver insufficiency, major renal insufficiency (creatinin clearance ≤ 30 ml/min)
Currently active alcohol or drug abuse, or history of alcohol or drug abuse within 24 weeks prior to screening
Patients with positive blood test for HIV
Inherited or acquired severe immune deficiency
Known active infection of any kind (excluding fungal infections of nail), or recent episode of infection, which has required oral antibiotic treatment within 2 weeks prior to enrollment in the trial
Infection having required hospitalization, or IV antibiotic treatment within 4 weeks prior to enrollment
Past history of severe infection such as fasciitis, osteomyelitis septic arthritis during the year prior to enrollment. Entry into this study may be reconsidered once the infection has fully resolved
Evidence of any new or uncontrolled concomitant disease that, in the investigator's judgment, would preclude patient participation, including but not limited to nervous system, renal, hepatic, endocrine, malignant, or gastrointestinal disorders
Any concomitant condition that required treatment with oral or systemic corticosteroids within 12 weeks prior to randomization
Major surgery within 4 weeks prior to randomization, excluding diagnostic surgery.
Patients having received immunosuppressive treatment (such as cyclosporine, mycophenolate mofetil, azathioprine), or any other treatment that might potentially be active on MMP lesions (anti-TNF) within 4 weeks prior to baseline.
Treatment with intravenous immunoglobulins, plasmapheresis, or other similar procedure within 8 weeks prior to randomization
Previous treatment of MMP with one of the test products: cyclophosphamide or rituximab
Previous treatment with a B cell-targeted therapy other than rituximab (e.g., anti-CD20, anti-CD22, or anti-BLyS)
Treatment with a live or attenuated vaccine within 28 days prior to randomization
Contraindication to MABTHERA 500 mg concentrate for solution for infusion
Contraindication to ENDOXAN 50 mg, tablets
Contraindication to methylprednisolone marketed as 120 mg powder for injectable solution pharmaceutical form
Contraindication to paracetamol marketed as 10 mg/ml solution for infusion pharmaceutical form
Contraindication to hydroxyzine marketed as 100 mg / 2 ml injectable solution pharmaceutical form
Contraindication to sodium chloride marketed as 0,9% sodium chloride solution for infusion pharmaceutical form
Contraindication to glucose marketed as 5% glucose solution for infusion pharmaceutical form
Lactose intolerance
Lack of peripheral venous access
Women pregnant or lactating, or intending to become pregnant during and for 12 months following the study. Women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative result from a serum pregnancy test within 1 week prior to randomization.
Patients who plan on having children (due to the risk of amenorrhoea/azoospermia related to cyclophosphamide) and due to the long retention time of rituximab in B cells depleted patients, women of childbearing potential should use effective contraceptive methods during and for 12 months following treatment with MABTHERA
Participation in another interventional clinical trial within 28 days prior to randomization and during the study
Person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)

Trial locations and contacts

27 sites in 1 country.

City, postcode or hospital

27 sites in 1 country

France27 sites

CHU Amiens
Amiens
CHU Angers
Angers
CH Argenteuil
Argenteuil
CHU Bordeaux
Bordeaux
Brest University Hospital
Brest
CHU Caen
Caen
CHU Clermont Ferrand
Clermont-Ferrand
CHU Dijon
Dijon
CH Le Mans
Le Mans
CHU Lille
Lille
CHU de Limoges
Limoges
HCL
Lyon
APHM La Timone
Marseille
CHU Montpellier
Montpellier
CHU Nantes
Nantes
CHU Nice
Nice
APHP Avicennes
Paris
APHP Bichat
Paris
APHP Cochin
Paris
APHP Henri Mondor
Paris
APHP Pitié Salpétrière
Paris
APHP Saint-Louis
Paris
CH Quimper
Quimper
CHU de Reims
Reims
CHU Rennes
Rennes
CHU saint-Etienne
Saint-Etienne
CHU Tours
Tours

Other trials in France

About this study

Official title: Randomized Double Blind Double Dummy Control Trial Comparing the Safety and Efficacy of Rituximab Versus Oral Cyclophosphamide in Severe Forms of Mucous Membrane Pemphigoid

Mucous membrane pemphigoid (MMP) describes a group of chronic auto-immune bullous diseases (AIBD) of the basement membrane zone (BMZ), characterized by predominant or exclusive mucosal involvement, including oral, naso-pharyngeal, laryngo-tracheal, genital, oesophageal, anal and ocular mucous membranes. Circulating autoantibodies are directed against various antigens of the BMZ: BP180, laminin 332 and type 7 collagen. MMP is a rare disease with an incidence of 1.8 new cases/million inhabitants/year in France.

Scar formation which is secondary to initial inflammation, is a characteristic feature of MMP, leading to major disability (e.g blindness and oesophageal, anal, vaginal stenosis) and life-threatening situations (e.g. laryngeal stenosis leading to respiratory failure).

Dapsone is the first line treatment of mild/moderate forms of MMP. Dapsone is used both as initial treatment, and as maintenance therapy. However, severe forms of MMP can rapidly worsen leading to blindness, aphagia due to esophageal stenosis, respiratory failure due to tracheal or laryngeal stenosis, and urinary and sexual dysfunctions due to genital involvement. These patients are usually treated using immunosuppressive drugs. Indeed, corticosteroids (CS) are not recommended in MMP.

Cyclophosphamide was considered as the most effective immunosuppressant in severe forms of MMP, before the use of rituximab, an anti-CD20 monoclonal antibody (MAb).

Two series from our group have assessed the advantages and disadvantages of IV pulse and oral administration of cyclophosphamide in MMP. Oral administration seems more rapidly effective with 54% of complete remission (CR) after a median time of 24 weeks (16-52 weeks).

The results of 41 patients with severe types of MMP (including a French series of 20 patients) treated with rituximab have been published. Rate of CR after one and two cycles were 66% and 90%, respectively. Clinical improvement was rapid, since a decrease in disease activity was observed after 4 weeks of treatment in 64% of patients.

Our results and those of the literature suggest that rituximab might be more effective than cyclophosphamide, which has been considered as the gold standard of treatment in severe forms of disease, up to now.

Conditions: Severe Forms of Mucous Membrane Pemphigoid
Being tested: Rituximab 1g IV, Cyclophosphamide 50Mg Oral Tablet, Placebo of Rituximab, Placebo Oral Tablet
Keywords: cyclophosphamide, Rituximab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Rituximab 1g IVDrug
Rituximab at a dose of 1000 mg will be administered by IV infusion on Day 1 and Day 15 whatever the patient's weight, with repeat maintenance rituximab (or matching placebo) administration on Day 182 and Day 197
Cyclophosphamide 50Mg Oral TabletDrug
cyclophosphamide will be administered orally once daily at the following initial doses:
- patients younger than 75 years: 1.5 mg/kg/day, orally.
- patients older than 75 years: 1 mg/kg/day, orally.
Placebo of RituximabDrug
Rituximab placebo will be administered by IV infusion on Day 1 and Day 15 whatever the patient's weight, with repeat maintenance rituximab administration on Day 182 and Day 197
Placebo Oral TabletDrug
cyclophosphamide placebo will be administered orally once daily

Study groups in NCT03295383
Study group	Role	What they receive
Rituximab treatment	Experimental	Rituximab at a dose of 1000 mg (or matching placebo) will be administered by IV infusion on Day 1 and Day 15 whatever the patient's weight, with repeat maintenance rituximab (or matching placebo) administration on Day 182 and Day 197 cyclophosphamide placebo will be administered orally once daily Receives: Drug: Rituximab 1g IV; Drug: Placebo Oral Tablet
Cyclophosphamide treatment	Active comparator	cyclophosphamide will be administered orally once daily at the following initial doses: patients younger than 75 years: 1.5 mg/kg/day, orally. patients older than 75 years: 1 mg/kg/day, orally. Rituximab placebo (NaCl 0.9 %) will be administered by IV infusion on Day 1 and Day 15 whatever the patient's weight, with repeat maintenance rituximab (or matching placebo) administration on Day 182 and Day 197 Receives: Drug: Cyclophosphamide 50Mg Oral Tablet; Drug: Placebo of Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of patients achieving CR or Partial Remission (PR)
Complete remission: absence of any inflammatory lesion, blister or erosion, and, absence of new fibrosing lesions, and/or absence of worsening of established fibrosing lesions Partial remission: presence of transient new inflammatory lesions, blisters or erosions that heal within one week without treatment and, absence of new fibrosing lesions, and/or absence of worsening of established fibrosing lesions. (Murrell D et al. 2015)
Measured: Month 12

Secondary outcomes (6)

Mean evolution of MMP DAI activity score
MMP DAI score is a scoring system who include 2 sub scores: the MMP DAI activity score which assesses disease activity (mucous membrane and skin erosions and blisters), and the MMP DAI damage score, which assesses disease damage (mucous membrane and skin scaring and pigmentation). These 2 "activity" and "damage" sub scores enable distinction between active erosions and blisters from post inflammatory changes and scarring from resolving lesions.
Measured: Month 24
Mean evolution of MMP DAI activity score
MMP DAI score is a scoring system who include 2 sub scores: the MMP DAI activity score which assesses disease activity (mucous membrane and skin erosions and blisters), and the MMP DAI damage score, which assesses disease damage (mucous membrane and skin scaring and pigmentation). These 2 "activity" and "damage" sub scores enable distinction between active erosions and blisters from post inflammatory changes and scarring from resolving lesions.
Measured: Month 6
Evolution of MMP DAI activity score
MMP DAI score is a scoring system who include 2 sub scores: the MMP DAI activity score which assesses disease activity (mucous membrane and skin erosions and blisters), and the MMP DAI damage score, which assesses disease damage (mucous membrane and skin scaring and pigmentation). These 2 "activity" and "damage" sub scores enable distinction between active erosions and blisters from post inflammatory changes and scarring from resolving lesions.
Measured: Month 12
Number of flares / relapses
relapse / flare is defined as "the reappearance of at least 3 new lesions a month (blisters, erosions) that do not heal within one week, or the extension of established lesions in a patient who has achieved disease control." (Murrell D et al. 2015).
Measured: Month 24
Evolution of quality of life score (TAB QOL)
ABQOL score is a quality of life questionnaires specifically developed for patients with autoimmune blistering disorders to assess quality of life (ABQOL)
Measured: Month 12
Evolution of quality of life score AB QOL
TAB QOL score is a quality of life questionnaires specifically developed for patients with autoimmune blistering disorders to assess evolution under treatment (TAB QOL)
Measured: Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jul 2019Mar 2027

First posted27 Sep 2017
Study start11 Jul 2019
Primary completionMar 2027 (estimated)
Study completionMar 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Severe Forms of Mucous Membrane PemphigoidStudies of the same condition, open and under way.
More trials run by University Hospital, RouenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 92 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03295383
Sponsor's protocol ID: 2015/208/HP
Acronym: RITUX-MMP
Status last verified: Jun 2026
First submitted: 22 Sep 2017
Last updated: 10 Jun 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Double Blind Double Dummy Control Trial Comparing the Safety and Efficacy of Rituximab Versus Oral Cyclophosphamide in Severe Forms of Mucous Membrane Pemphigoid
ClinicalTrials.gov ID: NCT03295383
Acronym / sponsor ID: RITUX-MMP / 2015/208/HP
Conditions: Severe Forms of Mucous Membrane Pemphigoid
Keywords: cyclophosphamide, Rituximab
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 92 participants (actual)
Lead sponsor: University Hospital, RouenUniversity, hospital or other
Study start: 11 Jul 2019 (actual)
Primary completion: Mar 2027 (estimated)
Study completion: Mar 2027 (estimated)
First posted: 27 Sep 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Cyclophosphamide was considered as the most effective immunosuppressant in severe forms of MMP, before the use of rituximab, an anti-CD20 monoclonal antibody (MAb).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Rituximab treatment	Experimental	Drug: Rituximab 1g IV, Drug: Placebo Oral TabletRituximab at a dose of 1000 mg (or matching placebo) will be administered by IV infusion on Day 1 and Day 15 whatever the patient's weight, with repeat maintenance rituximab (or matching placebo) administration on Day 182 and Day 197 cyclophosphamide placebo will be administered orally once daily
Cyclophosphamide treatment	Active comparator	Drug: Cyclophosphamide 50Mg Oral Tablet, Drug: Placebo of Rituximabcyclophosphamide will be administered orally once daily at the following initial doses: patients younger than 75 years: 1.5 mg/kg/day, orally. patients older than 75 years: 1 mg/kg/day, orally. Rituximab placebo (NaCl 0.9 %) will be administered by IV infusion on Day 1 and Day 15 whatever the patient's weight, with repeat maintenance rituximab (or matching placebo) administration on Day 182 and Day 197

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

Male or female patients aged ≥18 years old and ≤ 80 years old with a newly diagnosed or previously diagnosed severe MMP diagnosed according to the International MMP Consensus (Chan 2002) on the following criteria:
Clinical features: Blisters or erosions predominantly affecting any or all mucous membranes (oral, nasal, pharyngeal, laryngeal, anal, genital, or esophageal,) with or without clinically observable scarring. Ocular involvement includes conjunctival inflammation, shortening of fornices, symblepharon, ankyloblepharon, entropion, trichiasis and corneal neovascularisation.
Patients with skin involvement must not have more than 2 out of the 4 clinical criteria for bullous pemphigoid (BP) proposed by the French group (Vaillant L et al,1998; Joly P et al. 2004) Direct Immunofluorescence (DIF): Linear deposits of IgG, IgA and/or C3 on the BMZ by DIF of patient's skin or mucous membrane Histology: Sub epithelial blister with or without significant leukocyte infiltrate by standard histology of skin or mucosal lesions, when the skin or mucosal biopsy is possible and appropriate.
MMP is defined as "severe" in patients with:
Sight-threatening ocular disease, and/or Potentially life-threatening laryngeal, tracheal or oesophageal stenosis, and/or Involvement of a mucosal site where there is a risk of scarring stenosis (larynx, trachea, esophagus, anus, foreskin, vagina…) and/or More than one mucosal site involved and/or Mucosal involvement (including exclusive but severe oral involvement defined as an oral MMP DAI score > 10), and/or Skin involvement, which have not achieved control of disease activity despite a one month treatment with dapsone at the maximum dose tolerated or for patients with sight-threatening ocular disease, and/or potentially life-threatening laryngeal, tracheal or oesophageal stenosis, without previous treatment by dapsone

Key exclusion criteria (40 listed)

Patient < 18 years old or > 80 years old
Non-consenting patient or patient who cannot be followed regularly
Patients with only MMP sequelae (stenosis, fibrosis, without inflammation or disease activity)
Patients with Brunsting Perry pemphigoid and exclusive skin lesions without mucosal involvement
Karnofsky index < 50% (see Appendix 3)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Rituximab 1g IVRituximab at a dose of 1000 mg will be administered by IV infusion on Day 1 and Day 15 whatever the patient's weight, with repeat maintenance rituximab (or matching placebo) administration on Day 182 and Day 197	Drug	Rituximab treatment
Cyclophosphamide 50Mg Oral Tabletcyclophosphamide will be administered orally once daily at the following initial doses: * patients younger than 75 years: 1.5 mg/kg/day, orally. * patients older than 75 years: 1 mg/kg/day, orally.	Drug	Cyclophosphamide treatment
Placebo of RituximabRituximab placebo will be administered by IV infusion on Day 1 and Day 15 whatever the patient's weight, with repeat maintenance rituximab administration on Day 182 and Day 197	Drug	Cyclophosphamide treatment
Placebo Oral Tabletcyclophosphamide placebo will be administered orally once daily	Drug	Rituximab treatment

Primary outcome

Proportion of patients achieving CR or Partial Remission (PR)
Time frame: Month 12
Complete remission: absence of any inflammatory lesion, blister or erosion, and, absence of new fibrosing lesions, and/or absence of worsening of established fibrosing lesions Partial remission: presence of transient new inflammatory lesions, blisters or erosions that heal within one week without treatment and, absence of new fibrosing lesions, and/or absence of worsening of established fibrosing lesions. (Murrell D et al. 2015)

6 secondary outcomes

Mean evolution of MMP DAI activity score
Time frame: Month 24
Mean evolution of MMP DAI activity score
Time frame: Month 6
Evolution of MMP DAI activity score
Time frame: Month 12
Number of flares / relapses
Time frame: Month 24
Evolution of quality of life score (TAB QOL)
Time frame: Month 12
Evolution of quality of life score AB QOL
Time frame: Month 12

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pascal JOLY, Pr principal investigator

University Hospital, Rouen

27 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rituximab 1g IV and Cyclophosphamide 50Mg Oral Tablet in people with Severe Forms of Mucous Membrane Pemphigoid, run by University Hospital, Rouen at 27 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients achieving CR or Partial Remission (PR) (time frame: Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03295383.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.